CTRI

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CTRI Number

CTRI/2025/08/092678 [Registered on: 08/08/2025] Trial Registered Prospectively

Last Modified On:

08/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

It is study to know which drug have better effect from iv nalbuphine versus iv ketamine for the prevention of shivering after spinal anaesthesia

Scientific Title of Study

A prospective randomized study to compare the efficacy of intravenous nalbuphine versus intravenous low dose ketamine for prevention of post spinal anaesthesia shivering

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Vishal Babubhai Hadiya
Designation	Resident Doctor
Affiliation	Smt.Bhikhiben Kanjibhai Shah Medical Institute & Research Centre
Address	Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia Vadodara GUJARAT 391760 India
Phone	8469620185
Fax
Email	vishalhadiya098@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Jatin Patel
Designation	Professor
Affiliation	Smt.Bhikhiben Kanjibhai Shah Medical Institute & Research Centre
Address	Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Waghodiya, Piparia Vadodara GUJARAT 391760 India
Phone	9879368363
Fax
Email	dr_jatinpatel@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr Jatin Patel
Designation	Professor
Affiliation	Smt.Bhikhiben Kanjibhai Shah Medical Institute & Research Centre
Address	Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Waghodiya, Piparia GUJARAT 391760 India
Phone	9879368363
Fax
Email	dr_jatinpatel@yahoo.co.in

Source of Monetary or Material Support

Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara, Gujarat, India - 391760

Primary Sponsor

Name	Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre
Address	Waghodiya, Piparia, Vadodara, Gujarat, India - 391760
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Jatin Patel	Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre	2nd Floor, OT Complex, Anaesthesia department,Dhiraj Hospital, Sumandeep Vidyapeeth University Campus, waghodia, Pipariya, Vadodara, Gujarat, India 391760 Vadodara GUJARAT	9879368363 dr_jatinpatel@yahoo.co.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Sumandeep Vidyapeeth Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Inrtravenous Inj.Ketamine 0.5mg/kg	Intravenous Inj. Ketamine 0.5mg/kg will be given 15-20 mins after spinal anaesthesia
Intervention	Intravenous Inj. Nalbuphine 0.1mg/kg	Intravenous Inj. Nalbuphine 0.1mg/kg diluted till 10 ml in sterile NS will be given 15-20 mins after spinal anaesthesia

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1.Patients voluntarilly willing to sign informed consent. 2.Male or female patients between 18 to 65 years of age. 3.Patients with Body Mass Index less than 30 kg per m2 4.Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II. 5.Patients posted for elective surgeries under spinal anaesthesia

ExclusionCriteria

Details

1.Patients unwilling to participate in the study.
2.Patients with American society of Anesthesiiologist (ASA) physical status III, IV, V
3.Patients with Body Mass Index more than 30 kg per m2.
4.Patients with alcohol or other drug addiction.
5.Patients in which spinal anaesthesia coverted to general anaesthesia.
6.Patient with preexisting hoarseness or sore throat or upper respiratory tract infection.
7.Patients with cardiovascular diseases, Neurological diseases, Spinal Deformities and patient on opioid medications.
8.Patients with history of allergy to opioids.
9.Pregnancy & lactating women.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Alternation

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
To compare the efficacy of drugs for incidence and prevention of post spinal shivering using shivering score in patient undergoing spinal anaesthesia	At Baseline At time of Induction At time of giving drug at 10 mins after giving drug At 30 mins after giving drug At 60 mins after giving drug At 90 mins after giving drug

Secondary Outcome

Outcome	TimePoints
To compare the peri operative hemodynamic response	baseline at time of induction at time of drug administration 5 mins after drug 10 mins after drug 15 mins after drug 30 mins after drug 60 mins after drug 90 mins after drug also post in operative period at 0 hour at 1 hour at 2 hour at 3 hour at 6 hour at 12 hour at 24 hour

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

01/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="10"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

TITLE OF STUDY : PROSPECTIVE RANDOMIZED STUDY TO COMPARE THE EFFICACY OF INTRAVENOUS NALBUPHINE VERSUS INTRAVENOUS LOW DOSE KETAMINE FOR PREVENTION OF POST SPINAL ANAESTHESIA SHIVERING

Aim of the study : To compare the efficacy of intravenous nalbuphine and intravenous low dose ketamine in prevention of post spinal shivering in patients undergoing spinal anaesthesia.

Objectives of the study : 1.To compare the efficacy of drugs for INCIDENCE of post spinal shivering.

2. To compare the peri operative SHIVERING SCORE.

3. To compare the peri operative HEMODYNAMIC RESPONSE i.e. Heart rate (HR),

Non-invasive blood pressure (systolic blood pressure – SBP, diastolic

blood pressure – DBP and mean arterial pressure – MAP), Respiratory rate (RR),

Peripheral oxygen saturation (SpO2).

4. To compare the PERI OPERATIVE COMPLICATIONS, if any

Site of Study: Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat.

Study Design- Prospective randomized comparative Study

Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or by 12 months whichever is earlier.

SAMPLE SIZE – 60 patients

Patients will be divided into 2 groups (Group N and Group K) of 30 patients each by computerised method.

Group N will receive Inj. Nalbuphine 0.1mg/kg intravenous (diluted till 10ml) 20 minutes after spinal anaesthesia.

Group K will receive Inj. Ketamine 0.5mg/kg intravenous (diluted till 10 ml) 20 minutes after spinal anaesthesia.

INCLUSION CRITERIA:

• Patients voluntarilly willing to sign informed consent.

• Male or female patients between 18 to 65 years of age.

• Patients with Body Mass Index less than 30 kg per m2

• Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.

• Patients posted for elective surgeries under spinal anaesthesia.

EXCLUSION CRITERIA:

• Patients unwilling to participate in the study.

• Patients with American society of Anesthesiiologist (ASA) physical status III, IV, V

• Patients with Body Mass Index equal to or more than 30 kg per m2.

• Patients with alcohol or other drug addiction.

• Patients in which spinal anaesthesia coverted to general anaesthesia.

• Patient with preexisting hoarseness or sore throat or upper respiratory tract infection.

• Patients with cardiovascular diseases, Neurological diseases, Spinal Deformities and patient on opioid medications.

• Patients with history of allergy to opioids.

• Pregnancy & lactating women

ETHICAL ISSUES :

Written informed consent from all patients will be obtained a day prior to surgery.

• Permission will be taken from the ethical committee before conducting the study.

• All the drugs and techniques used in our study are routinely used.

• Patients are not expected to bear any cost for the purpose of study.

• Any change in the methodology will be informed to the ethical committee.

• It is a prospective comparative randomized study.

• On finding of any adverse reaction or side effects in the participating patients, it will be brought to the attention of the ethical committee.

STATISTICAL ANALYSIS :

Data will be collected & tabulated. Numerical variables will be presented as mean &

standard deviation (SD) while categorical variables will be presented as frequency and

percentage. As regard to numerical variables; tests like unpaired student t test and/or

ANNOVA will be used whenever appropriate for between groups comparison s, while

for categorical variables; chi square test will be used. p value <0.05 will be considered

statistically significant.

FEASIBILITY ISSUES :

It is a comparative, prospective and randomized study.

• Patients will not be expected to bear any extra cost for the purpose of study.

• All the drugs and technique used in our study are routinely used and are readily available in pharmacy.

• The hospital being a tertiary set-up, with sufficient IPD patient, the study is feasible in our set-up.

LIKELY OUTCOME OR BENEFITS OF STUDY:

This prospective randomized comparative study will help us to compare the efficacy between intravenous nalbuphine and intravenous ketamine for prevention of post spinal shivering in patients undergoing surgeries under spinal anaesthesia and will enable us to know which drug is most beneficial in giving balanced thermoregulation by having better outcomes based on hemodynamics outcomes and less post-operative complications.